The Food and Drug Administration (FDA) Aug. 31 amended the emergency use authorizations (EUAs) of the Pfizer-BioNTech and Moderna COVID-19 vaccines to include the bivalent formulations of the vaccines, which target not only the original SARS-CoV-2 variant, but also the current BA.4 and BA.5 subvariants.
The Centers for Disease Control and Prevention (CDC) on Sept. 1 endorsed its Advisory Committee on Immunization Practices’ recommendations for use of the updated bivalent COVID-19 boosters. The updated Pfizer-BioNTech booster will be offered to those ages 12 and older, while the updated Moderna booster will be available to those ages 18 and older.
For most people, who are not immunocompromised, CDC’s COVID-19 vaccination schedule recommends a bivalent booster dose administered at least two months after completion of the primary series or most recent booster dose. More information on booster eligibility can be found on the CDC’s COVID-19 booster tool.
Additionally, the agency notes that a person now is considered “up to date” with their COVID-19 vaccines if they have completed a COVID-19 vaccine primary series and received the most recent booster dose recommended for them by CDC.
Cases caused by the BA.5 subvariant of SARS-CoV-2 make up nearly 90 percent of all current COVID-19 cases, and many health leaders fear cases will continue to rise with possible fall and winter surges.
“As we head into fall and begin to spend more time indoors, we strongly encourage anyone who is eligible to consider receiving a booster dose with a bivalent COVID-19 vaccine to provide better protection against currently circulating variants,” said FDA Commissioner Robert Califf, MD.
Pfizer also announced plans to apply for EUA of an omicron-adapted bivalent vaccine designed for children ages 5 through 11 in early October. Additionally, the company is working with FDA to prepare an application for an omicron-adapted bivalent vaccine geared towards children ages 6 months through 4 years old.
Visit the America’s Essential Hospitals coronavirus resource page for more information about the pandemic.
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